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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX R2P METACROSS RX PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION R2P METACROSS RX R2P METACROSS RX PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number BD-P50040ER
Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
Please find below the results of our investigation. The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. We will submit a follow-up report as soon as the actual device testing is completed.
 
Event Description
Left radial access, 6fr 10cm slender, used gwa track 018, pre-dilated focal proximal sfa lesion (90%) with crosstella 2x40x200, then used angiosculpt 5x20x137,then exchanged for gwa 35 260cm, successfully delivered a misago 6x40x200, attempted to post dilate with abbott vascular armada 5x40x135 (not successful, would advance into 1/3 of the stent but no further), attempted to post dilate with r2p metacross 5x40x200 and noticed that while in the descending aorta, the balloon stopped advancing. Physician stopped and went to look. Catheter was visibly looped and the physician tried to advance and pull back to unloop the catheter. Unsuccessful. He then tried to remove the system (wire, balloon and sheath) but the balloon system started causing patient discomfort and resistance was observed. Everything was left in and the patient was transported by ambulance to the university of iowa for vascular surgery intervention. A radial cutdown was performed below the elbow and the system was removed in sections by using a wire cutter. The balloon system was intact but the catheter had kinked and was not able to straighten to remove. The patient received one unit of blood and a xenosure biologic patch to repair the radial artery. Good radial and ulnar pulses were observed at the end of the procedure.
 
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Brand NameR2P METACROSS RX
Type of DeviceR2P METACROSS RX PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka, osaka 53082 88
JA 5308288
Manufacturer (Section G)
KANEKA CORPORATION OSAKA PLANT
5-1-1
torikai-nishi
settsu, osaka 56600 72
JA 5660072
Manufacturer Contact
joji sengoku
1-12-32 akasaka
minato-ku
tokyo 10760-28
JA   1076028
MDR Report Key12244571
MDR Text Key264050943
Report Number3002808904-2021-00007
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBD-P50040ER
Device Catalogue NumberBD-P50040ER
Device Lot NumberSR030460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/29/2021 Patient Sequence Number: 1
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